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The Necessity of Pumps in Pharmaceutical Processes

The market for air, water, and energy products used in blood plasma fractionation, and the development of drugs derived from the plasma, is approaching $5 billion per year. Alongside this, the global market for pumps is approaching $40 million dollars per year. By Bob Mcilvaine, The Mcilvaine Company
 
Compared to many pharmaceutical processes, plasma fractionation is a large volume application. Nearly 100 million liters of plasma are produced each year, sourced from donors globally. Though a complicated processes, the human-derived plasma product market is still growing at approximately 6% per year.
Figure 1.
Figure 1.

Processes Involved in Blood Fractionation

Fractionation requires that donated blood first be separated into its component parts, namely platelets and plasma. This is usually done by centrifuging the blood, which allows erythrocytes (red blood cells) to settle at the bottom of the centrifuge.

When the blood has been treated in fractionation processes, it I s often used in transfusions. However, the processes for large scale, industrial plasma fractionation processes differ from those used in small scale operations.

Pump Utilization

In a biopharmaceutical process, pumps are needed to move fluids (e.g., buffer, media, and water for injection) through tubing to deliver them to the process equipment. Several types of positive displacement pumps are used, including peristaltic, diaphragm, rotary lobe, and gear pumps. In hygienic or sanitary uses, such as in biopharmaceuticals, pumps must prevent contamination and be able to be validated. Pumps may use single-use components or, if multi-use, be designed to be easily cleaned. Pumps must also be designed to meet appropriate standards for biopharmaceutical processing, such as the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standard.

Pumps are critical to minimizing the total cost of ownership for blood plasma fractionation. Purchasers need to know what products have the Lowest Total Cost of Ownership (LTCO) in each niche.

The Process

There are several different types of diaphragm pumps, including air-operated double-diaphragm (AODD) pumps, which are used for transferring fluids from one place to another and for ultrafiltration or diafiltration. AODD pumps do not have volumetric control. Diaphragm metering pumps on the other hand, have highly accurate volume control and are used in processes and for dosing. Applications include chromatography, buffer inline dilution, injection of fluids, and aseptic transfer of proteins, cells, and other materials. Figure 1 shows the pumps utilized in fractionation processes.

Pumps are used in the processing, but also the creation, of ultrapure water (water for injection) needed for the cleaning of in-place systems. Distillation and membrane filtration are two routes for achieving acceptable water purity, and both processes use pumps. However, pressure is the challenge in the membrane systems whereas temperature and steam are the challenges in distillation. Several examples of pump products and companies include: Cole Palmer by Masterflex, Finish Thompson, GEA, KNF, Netsch, PSG by Dover (Quantex), PSG by Dover (Quattroflow), SEEPEX, SPX, Sundyne ANSIMAG, and Watson Marlow.

Figure 2
Figure 2

Summary

There are many niches, suppliers, and pump types which need to be analyzed in order to achieve the lowest total cost of ownership in the manufacture of fractionation products. Due to the changing technology and market, the need for analysis is continuous. The opportunities for valve suppliers will keep changing.

About the Author

Bob McIlvaine founded the McIlvaine Company in 1974 and oversees the work of 30 analysts and researchers. He has a BA degree from Princeton University.

 

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